Keith Evans

This Weds 5/15, learn how Immuta helped revamp Merck’s #datamanagement strategy for the era of #AI and GxP compliance. With vast volumes of #data across various functions, Merck eliminated data siloes and developed a data marketplace to converge its data infrastructure and centralize access. https://bit.ly/4b60Nb3

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ZAGENO's VP of Growth, Nick Proch, had the pleasure of joining ProcureDesk's CEO, Sachin Sharma, to discuss the challenges biotech procurement faces and how to overcome them. During the webinar, they explored how a procurement maturity model can help assess your current state and guide your journey to increased efficiency and cost savings. 📈💰⚛️ To dive into learnings from a research ProcureDesk performed through interviewing 50+ biotech companies, watch the full webinar recording here: https://hubs.li/Q02Npy4F0 #biotech #procurement #supplychain #costcutting #efficiency #automation #ZAGENO #procuredesk #webinar

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Excited to share that our CEO Sachin Sharma recently teamed up with Nick Proch, VP of Growth at ZAGENO Inc. to dive into the key challenges in biotech procurement. They explored how a Procurement Maturity Model can drive efficiency and cut costs—helping businesses operate smarter and leaner. 💡 Catch the full conversation here ⬇ https://hubs.li/Q02Npy4F0 #biotech #procurement #supplychain #costsavings #efficiency #automation #zageno #procuredesk

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Great "Ask the Expert session this afternoon" Some of the questions posed will be integrated into our webinars next week. EAPs - What, Why, Where, When and Who? 🔍 What are these programs? 🔍 Why should an innovator initiate an EAP? 🔍 Where should (could) they be initiated? 🔍 When should they be initiated? 🔍 Who should be included in the program? Date 1: Monday, 23 September, 10:00 Pacific / 13:00 Eastern USA 👉🏼 https://lnkd.in/eWiBy4cu Date 2: Wednesday, 25 September, 16:00 CET / 10:00 Eastern USA 👉🏼 https://lnkd.in/emguiKsp #EarlyAccessPrograms #ExpandedAccessPrograms #SmartwayEAP

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Accelerate regulatory submissions and lifecycle variations through automation and effective global-to-local collaboration on core packages. Learn how: https://bit.ly/3UdapLc #RIM #regulatory #submissions #biopharma

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In a rapidly evolving biopharma landscape, ensuring supply chain resilience and mitigating biosecurity risks have become paramount. Alex Del Priore, Senior Vice President, Manufacturing Services at Syngene notes, "The industry is experiencing a significant shift in manufacturing locations, gravitating towards the east. Additionally, lessons from the pandemic emphasize the importance of supply chain resilience, resulting in a trend towards risk diversification." With state-of-the-art facilities approved by regulatory bodies like the US FDA, EMA, and MHRA, "The opportunity for Syngene is that we have almost unique large and small molecule capabilities from discovery to commercial. So, as a full-service provider, we are a very attractive partner," remarks Alex Del Priore. Read the full article, link in comments section 🔗 #Biosecure #Pharmaceuticals #SupplyChain #Syngene #CDMO Manufacturing Chemist

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Faster FDA approval through Real-World Evidence? Absolutely! FDA is incorporating RWE into regulatory decisions, helping pharmaceutical companies streamline the approval process. Learn how RWE can benefit your product's journey. #FDAApproval #RWE #CommercialStrategy #FacetLifeSciences https://hubs.ly/Q02Vb54y0

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Emerging and mid-cap biopharma companies often face tight budgets, making it crucial to maximize value. Outsourcing field services to a commercialization partner can help maximize resources while competing with more established companies. Discover the five key qualities to look for in a field services partner: https://ow.ly/egv550T8Fmu

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Our bet is you are facing these common RIM challenges like everyone in the life sciences sector. From navigating regulatory changes to managing submissions and ensuring compliance, our insights on Veeva Vault RIM can help overcome these obstacles. Learn how fme leverages Veeva to support your company's growth. #LifeSciences #RegulatoryChallenges #VeevaVault

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Traditional tools may have served CROs well in the past, but as clinical trials grow more complex, they can create bottlenecks and financial blind spots that hinder scalability. George Woods explains how the right ERP system is the key to unlocking sustainable growth in today’s competitive life sciences market. Check out the blog here: https://lnkd.in/gnJKwrMN   #LifeSciences #CRO #ERPSystems #ClinicalTrials #BusinessGrowth

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Missed our webinar on biologics and healthcare logistics? Nik Lambeth shares insights on how good supply chain design ensures the safe, timely delivery of fragile, high-value therapies. Watch the full discussion and learn ways to meet the challenges of biologics head-on. https://okt.to/Majxzs

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🚀 Unlock Your Competitive Edge in Life Sciences Manufacturing! 🚀 Join our webinar tomorrow with Kneat’s Mo Brar as he reveals how mastering validation can transform your development and production processes. Learn to tackle validation challenges and enhance data integrity, quality, and efficiency for CDMOs. RSVP Now: https://hubs.li/Q02SKX-r0 #LifeSciences #Manufacturing #Validation #CDMO #CMO #Webinar

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Staying ahead in a complex regulatory environment is crucial. Our whitepaper on intelligent automation in regulatory information management offers a roadmap for success. Learn from industry leaders and transform your operations. Get your copy here: 👉 https://bit.ly/4dHGfXg 👈 #WeAreCGI #LifeSciences #CGIUS

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Join us on October 8 in Cambridge, MA, at our Regulatory Transformation Forum. Hear from Kevin O'Leary and connect with industry leaders to explore emerging capabilities and how to harness them for data-driven advancements in KASA, IDMP, FHIR standards and dossier automation. Key topics: 🚀 Overcoming data challenges to drive automation, data reuse and accuracy in dossier authoring 🔥 Enhancing data automation and authoring efficiency while preparing for FHIR standards 📈 Building confidence and advancing digital strategic imperatives 👇 Head to the comments to register!

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𝗟𝗲𝘀𝘀𝗼𝗻𝘀 𝗳𝗿𝗼𝗺 𝗧𝗵𝗲 𝗣𝗵𝗼𝗲𝗻𝗶𝘅 𝗣𝗿𝗼𝗷𝗲𝗰𝘁: 𝗔 𝗠𝘂𝘀𝘁-𝗥𝗲𝗮𝗱 𝗳𝗼𝗿 𝗜𝗧 𝗮𝗻𝗱 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗟𝗲𝗮𝗱𝗲𝗿𝘀 The Phoenix Project by Gene Kim, Kevin Behr, and George Spafford tells the story of Parts Unlimited, a company on the brink of failure due to mismanaged IT projects and outdated operational practices. At the center is Bill Palmer, who unexpectedly becomes the VP of IT Operations and takes charge of rescuing the company’s most critical initiative: the “Phoenix Project.” With growing inefficiencies and rising costs, Bill turns to Erik, a mentor who introduces him to lean manufacturing principles and the Three Ways of DevOps: 𝗳𝗹𝗼𝘄, 𝗳𝗲𝗲𝗱𝗯𝗮𝗰𝗸, 𝗮𝗻𝗱 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗼𝘂𝘀 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴. By applying these concepts, Bill: - Improves IT workflow, reduces work-in-progress (WIP), and fosters better communication across development, operations, and business teams. - Automates repetitive tasks to minimize errors and enhance productivity. - Focuses on streamlining value delivery across the organization. The book emphasizes valuable lessons, including: - IT as a driver of business growth through innovation. - The importance of breaking down silos with interdepartmental collaboration. - Leadership's role in empowering teams and fostering a culture of continuous improvement. The Phoenix Project serves as an essential guide for organizations seeking to embrace IT and DevOps practices to enhance performance, agility, and resilience. Have you read it? What lessons resonated with you? #ThePhoenixProject #DevOps #ITManagement #BusinessTransformation #LeanIT #DigitalTransformation #Leadership #Innovation #Collaboration

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For the last six years, #ModelN has set out to uncover how life sciences manufacturing executives are embracing opportunities and overcoming challenges in modern revenue optimization and #compliance. This year's report aimed to answer several questions, including what is the state of #data analytics in revenue management? Learn more and read the full report here: https://lnkd.in/e-VPfBcT #RevenueOptimization #RevenueManagement #LifeSciences

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Navigating #coldchain complexity to enable clinical-to-commercial transition of #advancedtherapies The pharmaceutical industry is advancing rapidly, propelled by the development of novel therapies that require stringent temperature-controlled environments. This month, join Thermo Fisher Scientific’s Susan Li (Senior Client Services and Solutions Director) as she explores the critical challenges in maintaining the integrity of the cold chain, which is vital for ensuring the efficacy and safety of temperature-sensitive products such as cell and #genetherapies, #vaccines, and other biologics Attend to learn about: • Key bottlenecks in cold chain logistics for high-value, temperature-sensitive therapies • The importance of maintaining integrity from clinical to commercial phases • The future of cold chain management and strategies to optimize advanced therapy clinical trials Register for this upcoming #webinar below: https://buff.ly/3KQK2oH

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I often receive the question: How long does it take KORIO to make a change in the RTSM? The two-word answer is one I am sure the recipient hates getting – and for what it’s worth, I hate giving it more. It depends. We’ve seen our share of innovative ideas over the years that sidestep reality – and there is often no silver bullet for mid-study changes. However, there are several areas in the process that we can see a significant improvement in quality and time (and of course, cost). Whether you are a small biotech that is stuck in line, waiting as your RTSM vendor prioritizes higher-profile accounts - or you’re a larger organization who is looking for ways to make platform-level changes that can hit multiple studies at once, there is something for everyone with Korio’s approach to RTSM. Please take a look at this latest blog and reach out to discuss more on this topic!

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